NCT00984295

Frozen ProQuad Administered Concomitantly Versus Nonconcomitantly With Other Pediatric Vaccines

An Open, Randomized, Multicenter Study of the Safety, Tolerability, and Immunogenicity of Frozen MMRV Given Concomitantly Versus Nonconcomitantly With Other Pediatric Vaccines in Healthy Children 12 to 15 Months of Age

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,913 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 12 Months – 15 Months
• Healthy volunteers: Accepted

Summary

This study will assess the safety and immunogenicity of ProQuad when administered concomitantly and nonconcomitantly with Tripedia and Comvax.

Conditions

• Measles
• Mumps
• Rubella
• Varicella

Interventions

Type	Name	Description
BIOLOGICAL	Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live	A single 0.5 mL subcutaneous injection at Day 0
BIOLOGICAL	Comparator: Tripedia	A single 0.5 mL intramuscular injection (at Day 0 or Day 42)
BIOLOGICAL	Comparator: Comvax	A single 0.5 mL intramuscular injection (at Day 0 or Day 42)
BIOLOGICAL	Comparator: Varivax	A single 0.5 mL subcutaneous injection at Day 0
BIOLOGICAL	Comparator: M-M-R II	A single 0.5 mL subcutaneous injection at Day 0

Timeline

• Start date: 2000-06-01
• Primary completion: 2001-10-01
• Completion: 2001-12-01
• First posted: 2009-09-25
• Last updated: 2015-08-07
• Results posted: 2010-02-25